Gardasil

DRUG DESCRIPTION

GARDASIL, Human Papillomavirus Quadrivalent (Types 6, 11,
16, and 18) Vaccine, Recombinant, is a non-infectious recombinant quadrivalent
vaccine prepared from the purified virus-like particles (VLPs) of the major
capsid (L1) protein of HPV Types 6, 11, 16, and 18. The L1 proteins are
produced by separate fermentations in recombinant Saccharomyces cerevisiae and
self-assembled into VLPs. The fermentation process involves growth of S.
cerevisiae on chemically-defined fermentation media which include vitamins,
amino acids, mineral salts, and carbohydrates. The VLPs are released from the
yeast cells by cell disruption and purified by a series of chemical and
physical methods. The purified VLPs are adsorbed on preformed
aluminum-containing adjuvant (Amorphous Aluminum Hydroxyphosphate Sulfate). The
quadrivalent HPV VLP vaccine is a sterile liquid suspension that is prepared by
combining the adsorbed VLPs of each HPV type and additional amounts of the
aluminum-containing adjuvant and the final purification buffer.

Each 0.5-mL dose of the vaccine contains approximately
225 mcg of aluminum (as Amorphous Aluminum Hydroxyphosphate Sulfate adjuvant),
9.56 mg of sodium chloride, 0.78 mg of L-histidine, 50 mcg of polysorbate 80,
35 mcg of sodium borate, < 7 mcg yeast protein/dose, and water for injection.
The product does not contain a preservative or antibiotics.

After thorough agitation, GARDASIL is a white, cloudy
liquid.

What are the possible side effects of human papillomavirus vaccine (Gardasil)?

You should not receive a booster vaccine if you have had a life-threatening allergic reaction after the first shot.

Developing cancer from HPV is much more dangerous to your health than receiving the vaccine to protect against it. However, like any medicine, this vaccine can cause side effects but the risk of serious side effects is extremely low.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Before receiving this medication, tell your doctor or pharmacist if you are allergic to it; or to other vaccines; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.